Research Scientist

• Handle execution of drug product technology transfer, product life cycle activities, material qualification, and cleaning validation
• Support NPI using applicable tools and standards in collaboration with Virtual Management Team (VMT), key supply chain functions, Technical launch integrators / owners, and EM site
• Act as Technical coordinator for CMO process technology proficiency assessment, technology standards, and implementation of MSAT Technology Roadmaps
• Serve as primary contact and site owner for technical issues related to EM and represent in VMT by being a single technical voice including EM, thus supporting decision / actions
• Maintain and develop good understanding of the status regarding ongoing and future planned technical activities at site
• Engage in Site Lifecycle processes (due diligence / selection, onboarding, engage, ongoing monitoring, disengage) including support to localization; also be involved in technical assessment / due diligence of product portfolio / in- licensing
• Support working models and tools in handling EM from technical perspective which includes Technical risk metrics & Switching Effort / Complexity metric for fit-for-purpose segmentation model, and account planning/adherence
• Conduct technical assessment of change controls and other quality related activities by associating with Quality for audits and inspections
• Provide technical support on site for investigations and resolution of deviation / OOS (process, cleaning, troubleshooting) by collaborating with engineering, product launch, and technical owners

Principal Scientist, MSAT Synthetics Liquid DP

• Lead statistical strategy and execution for projects including solubility modeling and prediction; accelerated stability and shelf-life estimation; reaction trend fingerprinting and outlier detection; dissolution modeling; mechanistic modeling; and spectral analytics (ssNMR, THz-Raman, XRD)
• Develop design of experiments and Bayesian Optimization workflows to accelerate method development and reaction optimization
• Lead chemometric and spectral analysis pipelines
• Work closely with researchers on experimental design, data analysis, interpretation, and clear communication of evidence to support research, development, and product commercialization
• Co-author scientific publications and present research findings at internal and external forums
• Build and maintain trusted relationships with colleagues and stakeholders through clear, reliable statistical guidance
• Support internal capability building through statistical trainings, mentorship, and the development and dissemination of best practices and reproducible workflows

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Principal Scientist, MSAT Synthetics Liquid DP

Principal Scientist, Manufacturing Statistics